Application 214654

Type
ANDA
Sponsor
YICHANG HUMANWELL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 37.5MG BASENoNo
002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 75MG BASENoNo
003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 150MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214654-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06
A214654-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06
A214654-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A214654-001AB
A214654-002AB
A214654-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214654-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214654-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214654-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214654-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214654-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214654-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214654-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214654-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214654-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214654-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214654-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214654-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214654-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214654-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214654-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214654-001AB18072bd15b7f6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSb1d21366-f686-4e20-a10f-0c25f517db382026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsf50029b8-7d05-445a-9d9f-71a1aee6088b2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions5a990dbd-f280-4caf-b950-4703ee98b2302026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsd94e5404-f728-4e4b-af99-8a8e4dfae2272026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsc37a73fa-ceee-4555-a61b-e1e66ad6e97d2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.7fcd7995-81fb-4368-bd4c-3726b2ae363e2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEEpic Pharma, LLC430777f0-347c-4f21-8c5d-55f4e9897e742026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
ndc (product): 42806-601
ndc (product): 42806-603
ndc (product): 42806-602
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackd7d1319c-500e-4ca0-83a1-a739cfa01cf72026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackea5914ab-28f3-4cb3-bade-6eaccac214e42026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions0a1b6bcd-8d46-44ab-bc5d-65515601d2ff2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.b055df74-51f9-401f-8cca-24269a0163df2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.92b3f73d-d6ca-4d7d-9035-5700f527cb852025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.33b39416-7981-46fb-ba31-e933a6afcf8b2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.963e5599-f9af-45c2-8cf4-13cf52eed6a02025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine Hydrochloride ERVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf7a9741b-2dd3-d8f3-e053-6294a90a4d732024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2a85bd43-419c-6ed7-e063-6294a90a84d42024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.1e04fe02-88c9-dafd-e063-6294a90ac4c92024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1bf78b22-a0e3-5f9f-e063-6394a90a30242024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC19b1543e-d599-a869-e063-6294a90a8e282024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-601Venlafaxine HydrochlorideVenlafaxine HydrochlorideEpic Pharma, LLCANDACurrent
42806-601Venlafaxine HydrochlorideVenlafaxine HydrochlorideEpic Pharma, LLCANDACurrent
42806-602Venlafaxine HydrochlorideVenlafaxine HydrochlorideEpic Pharma, LLCANDACurrent
42806-602Venlafaxine HydrochlorideVenlafaxine HydrochlorideEpic Pharma, LLCANDACurrent
42806-603Venlafaxine HydrochlorideVenlafaxine HydrochlorideEpic Pharma, LLCANDACurrent
42806-603Venlafaxine HydrochlorideVenlafaxine HydrochlorideEpic Pharma, LLCANDACurrent